MAUDE Adverse Event Report: SUNMED HOLDINGS LLC. MEDLINE; RESUSCITATOR BAG

Model Number CPRM1116M

Device Problems Fitting Problem (2183); Connection Problem (2900)

Patient Problems No Known Impact Or Consequence To Patient (2692); Missing Value Reason (3192)

Event Date 09/01/2018

Event Type  malfunction  

Manufacturer Narrative

Affected product was returned and the defect was confirmed.Masks were 100% inspected during assembly for any mask port roundness.Deformation of masks occurred after assembly.

Event Description

The customer alleges that "the valve on mask is misshapen".No other details were provided and no patient injury/harm reported.

• Brand Name: MEDLINE
• Type of Device: RESUSCITATOR BAG
• Manufacturer (Section D): SUNMED HOLDINGS LLC.; 2710 northridge dr. nw; suite a; grand rapids MI 49544
• Manufacturer (Section G): SUNMED HOLDINGS LLC.; 2710 northridge dr. nw; suite a; grand rapids MI 49544
• Manufacturer Contact: carrie fortuna ; 2710 northridge dr. nw.; suite a; grand rapids, MI 49544 ; 6162598400
• MDR Report Key: 7922388
• MDR Text Key: 122645986
• Report Number: 1314417-2018-00036
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CPRM1116M
• Device Lot Number: 314853
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1